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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY TOTAL ANKLE SYSTEM PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

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WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY TOTAL ANKLE SYSTEM PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Model Number 200009901
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 06/22/2021
Event Type  Injury  
Manufacturer Narrative
Device will not be returned. If additional information becomes available, it will be provided on a supplemental report. Device not available.
 
Event Description
It was reported that the patient underwent a total ankle surgical procedure. Allegedly, the base stem was dropped on the floor and the hospital would not process due to the ifu instructions. This was the only 16mm base stem in the kit, as only one of this size is standard in the kit. The 18mm stem would not fit on the tibia tray that was needed, so there was no back up available. A cement spacer was put into the joint space and the patient had to undergo a second surgical procedure the following day.
 
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Brand NameINFINITY TOTAL ANKLE SYSTEM
Type of DevicePROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
WRIGHT MEDICAL TECHNOLOGY, INC.
11576 memphis arlington rd
arlington TN 38002
Manufacturer (Section G)
WRIGHT MEDICAL TECHNOLOGY, INC.
11576 memphis arlington rd
arlington TN 38002
Manufacturer Contact
nathe hendricks
1023 cherry rd
memphis, TN 38117
9014516318
MDR Report Key12193508
MDR Text Key262428113
Report Number0001043534-2021-00122
Device Sequence Number1
Product Code HSN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K051023
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number200009901
Device Catalogue Number200009901
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/19/2021 Patient Sequence Number: 1
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